Randomized phaseII study of S-1 and concurrent radiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer. (JCOG1106)

Randomized phaseII study of S-1 and concurrent radiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer. (JCOG1106) - Randomized phaseII study of S-1 and concurrent radiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer. (JCOG1106)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006811

Enrollment

100

Registered

2011-12-01

Start date

2011-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

locally advanced pancreatic cancer

Interventions

A:Patients receive concurrent radiotherapy with S-1 followed by additinoal chemotherapy until obvious evidence of disease progression, patient refusal, or unacceptable toxicity. Concurrent radioth

80mg/m2 on the irradiated day Radiotherapy

a total dose of 50.4 Gy in 28 fractions Additional chemotherapy: Gemcitabine

1000 mg/m2/day, days 1, 8, and 15 every 4 weeks B:Patients receive induction chemotherapy followed by concurrent radiotherapy with S-1 and additinoal chemotherapy until obvious evidence of disease pr

1000 mg/m2/day, days 1, 8, and 15 every 4 weeks Concurrent radiotherapy with S-1: S-1

a total dose of 50.4 Gy in 28 fractions Additional chemotherapy: Gemcitabine

1000 mg/m2/day, days 1, 8, and 15 every 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven adenocarcinoma and consistent with papillary adenocarcinoma, tubular adenocarcinoma, poor differentiated adenocarcinoma, or adenosquamous carcinoma by diagnostic imaging 2) Without obvious organ metastasis (UICC-M0) by diagnostic imaging 3) Diagnosed as UICC-T4 by abdominal CT or MRI 4) All pancreas lesions and lymph node metastases are included in the radiation field, 10 x 10 cm 5) Without ascites/pleural effusion by abdominal CT/chest X-ray 6) Without gastroduodenal ulcer (except for ulcer scar) 7) Without obvious direct invasion to digestive tract 8) Aged 20 to 80 years old 9) ECOG PS of 0 or 1 10) No prior surgical treatment for pancreatic cancer (except for exploraratory laparotomy, choledochojejunostomy and gastrojejunostomy) 11) No previous chemotherapy or radiotherapy against any other malignancies 12) Adequate organ functions 13) Written informed consent"

Exclusion criteria

Exclusion criteria: 1) Interstitial pneumonia or fibroid lung 2) Watery diarrhea 3) Severe complication, such as heart disease, renal disease, and hepatic disease 4) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium 5) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 6) Active infection requiring systemic therapy 7) Fever over 38 degrees Celsius 8) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 9) Psychosis 10) Patients requiring systemic steroids medication 11) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy "

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
CA19-9 response, distant metastasis-free survival, progression-free survival, adverse events, delayed toxicity, treatment-related death, early death, grade 4 non-hematological toxicity	—

Countries

Japan

Contacts

Public ContactAkira FUKUTOMI

JCOG1106 Coordinating Office Shizuoka Cancer Center, Division of GI Oncology

JCOG_sir@ml.jcog.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026